Eftilagimod alpha + chemo+ anti-PD-1 - (INSIGHT-003)

July 13, 2026: Immutep Limited (ASX: IMM; NASDAQ: IMMP) reported a positive update from the investigator-initiated INSIGHT-003 Phase I trial of eftilagimod alfa (efti) plus pembrolizumab (KEYTRUDA) and chemotherapy as 1L treatment for advanced/metastatic non-squamous NSCLC (51 evaluable patients). At the March 27, 2026 data cutoff with a minimum 30 months’ follow-up, median overall survival (mOS) was 30.9 months in the overall population (N=51) and also 30.9 months in patients with PD-L1 TPS <50% (N=47); mOS was 37.8 months in TPS ≥50% (N=4). ~92% of enrolled patients had TPS <50%. No new safety signal was identified since the prior cutoff.

The company also provided an update on the discontinued TACTI-004 Phase III 1L NSCLC trial: following a planned interim futility analysis (N=173), the IDMC recommended stopping; ORR was 42.9% in the efti arm vs 55.1% in control, with no superiority in any TPS subgroup. Root cause analysis is ongoing, including preliminary immune monitoring findings and manufacturing as a potential factor; additional results are expected in Q3 CY2026.